Incidence of Endophthalmitis after intravitreal injections with and without prophylactic antibiotics

2018/2019 Diogo Dias Ramos Incidence of Endophthalmitis after Intravitreal Injections with and without Prophylactic Antibiotics Incidência de Endoftalmite após Injeções Intravítreas com e sem Profilaxia Antibiótica março, 2019 Mestrado Integrado em Medicina Área: Oftalmologia Tipologia: Dissertação Trabalho efetuado sob a Orientação de: Doutor Manuel Alberto de Almeida e Sousa Falcão Trabalho organizado de acordo com as normas da revista: Ophthalmology Retina Diogo Dias Ramos Incidence of Endophthalmitis after Intravitreal Injections with and without Prophylactic Antibiotics Incidência de Endoftalmite após Injeções Intravítreas com e sem Profilaxia Antibiótica março, 2019 Dedicatória Aos meus pais, José Luís da Silva Ramos e Maria da Conceição Santos Dias Ramos, que todos os dias fazem dos meus sonhos os seus próprios e me mostram que com amor, dedicação e trabalho tudo se consegue atingir. Obrigado por acreditarem em mim, mesmo nos momentos em que não acredito em mim mesmo. 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Muito Obrigado. 1 Title Incidence of Endophthalmitis after Intravitreal Injections with and without Prophylactic Antibiotics Authors and affiliation Diogo Dias Ramos1, Sónia Torres Costa, MD2, Manuel Sousa Falcão, MD, PhD2,3 1FMUP – Faculty of Medicine, University of Porto 2Ophthalmology Department, Centro Hospitalar de São João, Oporto, Portugal 3Surgery and Physiology Department, Centro Hospitalar de São João, Oporto, Portugal Corresponding Author Diogo Dias Ramos Faculty of Medicine, University of Porto Al Prof Hernâni Monteiro, 4200-319, Porto, Portugal Tel +351 225 51 3600, Fax +351 225 51 3601 Email: [email protected] Financial Support: None Conflict of Interest: No conflicting relationship exists for any author. Abbreviations/ Acronyms IVI – Intravitreal Injections; Anti-VEGF – Anti-Vascular Endothelial Growth Factor; AMD – age-related macular degeneration; DME – diabetic macular edema; RVO – retinal vein occlusion; PPV – pars plana vitrectomy; VA – Visual Acuity; logMAR – logarithm of the minimal angle of resolution; CF – count fingers; HM – hand motion; OR – operating room 2 ABSTRACT Purpose: To assess the effect of topical antibiotic prophylaxis on the rate of post-operative endophthalmitis after intravitreal injection (IVI) of anti-vascular endothelial growth factor agents (VEGF) and corticosteroids and to describe the clinical characteristics, management, and visual outcomes of patients with acute endophthalmitis. Design: Retrospective, single-center study. Participants: All patients treated with intravitreal injections for a variety of retinal pathologies between 1 October 2014 and 30 November 2018 were included. Methods: The intravitreal injections performed during a two-year period in which topical antibiotic prophylaxis was used was compared to the number of injections performed over a two-year period without antibiotic prophylaxis. Main Outcome Measure: Incidence of clinical endophthalmitis in the two different groups. Results: Between 1 October 2014 and 30 November 2018, 33515 IVI were performed. During this period, 13 cases of post-IVI endophthalmitis were identified (incidence rate of 0.0388%; 95% CI, 0.0217-0.0644%) or approximately 1 case for every 2578 IVI performed. Between 1 October 2014 and 31 October 2016, when post-operative topical antibiotic prophylaxis was used 14828 IVI were performed and 5 cases of endophthalmitis were reported (0.0337%; 95% CI, 0.0129-0.0739%); between 1 November 2016 and 30 November 2018, when no prophylaxis was used, 18687 IVI were performed and 8 cases of endophthalmitis were identified (0.0428%; 95% CI, 0.0202-0.0808%). There were no statistical differences in the incidence rates between the two groups (p=0.675). The median number of days from injection to presentation was 7.0 (range 2-24 days). Conclusions: The incidence of endophthalmitis after IVI of anti-vascular endothelial growth factors or corticosteroids was low. Post-IVI antibiotic prophylaxis did not reduce the rate of endophthalmitis. Changing the policy from antibiotic prophylaxis to no antibiotic prophylaxis was safe. Keywords: endophthalmitis, antibiotic prophylaxis, intravitreal injection, anti-vascular endothelial growth factor. 3 INTRODUCTION The number of intravitreal injections (IVI) performed has grown exponentially in the past decade, becoming the most commonly performed invasive ophthalmic procedure.1,2 In the USA alone, there was an estimated 5.9 million IVI performed in 2016.3 With the institution of intravitreal anti-vascular endothelial growth factor (anti-VEGF) and corticosteroids for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusions (RVO) an exponential increase in the number of IVI was observed. IVI became the standard of care for the mentioned diseases.4–7 However, it is important to state that all these diseases are chronic diseases that require frequent retreatments. IVI of anti-VEGF agents are usually started on a monthly basis. As time elapses, different treatment strategies such as pro re nata or “Treat and Extend” strategies have been employed to try and reduce the number of injections. Nonetheless, some patients may have up to twelve injections each year. IVI may induce complications, including endophthalmitis, retinal detachment, and cataract.8 Infectious endophthalmitis is the most preoccupying complication after IVI because of its poor prognosis resulting in severe and irreversible vision loss.9 Although the risk is low, with the largest meta-analysis reporting a frequency of 0.056% (197/350.535 injections)10, since we are talking about chronic macular pathologies with repeated IVI being required, the cumulative risk after 2 years is often more than 1%.11 By 2004, IVI was a fairly uncommon procedure and, as such, guidelines at that time mentioned the use of preand/or post-injection topical antibiotics.12,13 Despite the lack of evidence showing any efficacy in preventing post-injection endophthalmitis, it was always an accepted practice to use topical antibiotics since many clinical trial protocols for intravitreal agents required them.14,15 Using topical antibiotics for prophylaxis up to twelve weeks in one year can potentially lead to the selection of resistant microbiologic strains.16– 18 The widespread use of IVI has considerably increased the body of evidence regarding post-injection endophthalmitis. Many studies have identified modifiable risk factors to prevent endophthalmitis following IVI, and guidelines based on current best evidence and practices have been published in different countries.12,19 However, while some have been applied in present clinical practice, no consensus was established about the use of topical prophylaxis with antibiotics. 4 Povidone-iodine with strict antisepsis rules is the only prophylaxis that was proven to have an effect against endophthalmitis after intra-ocular surgery.13,20,21 Some studies are starting to suggest the lack of role of topical antibiotics in the prevention of post-injection endophthalmitis.22–24 In fact, recent studies even suggested that topical prophylaxis with antibiotics may be harmful and increase the risk of endophthalmitis.16,18,25 The purpose of this study is to assess the effect of topical antibiotic prophylaxis on the rate of post-operative endophthalmitis after IVI of anti–VEGF agents or corticosteroids and to describe the clinical characteristics, management, and visual outcomes of patients with acute endophthalmitis following IVI. PATIENTS AND METHODS STUDY DESIGN: This is a retrospective study of endophthalmitis after intravitreal injections (IVI) given from 1 October 2014 and 30 November 2018 performed at Centro Hospitalar Universitário de São João, Oporto, Portugal. We compared the 25-month prior to the suspension of the antibiotic prophylaxis (from 1 October 2014 to 31 October 2016) to the immediately following 25-month period (from 1 November 2016 to 30 November 2018) during which no prophylaxis was prescribed. This study was approved by the local Ethics Committee of Centro Hospitalar Universitário de São João. Medical records were used to identify the total number of intravitreal injections and the setting in which intravitreal injections were performed. The treatments included in this study were ranibizumab (0.5 mg/0.05 mL; Lucentis; Novartis Pharma SAS; Basel, Switzerland), bevacizumab (1.25 mg/ 0.05 mL; Avastin; Roche, Basel, Switzerland), aflibercept (2 mg/0.05mL; Eylea; Bayer Pharma AG; Berlin, Germany), triamcinolone acetonide (2mg/0,1mL and 4 mg/0.1 mL; Kenalog; Bristol-Myers Squibb, New York, New York, USA), dexamethasone implant (0.7 mg; Ozurdex; Allergan SAS, Irvine, CA, USA), and the fluocinolone acetonide implant (0.19mg; Iluvien; Alimera Sciences Inc; Hampshire, UK). Indications for intravitreal injection included macular edema secondary to diabetic retinopathy, retinal vein occlusion and uveitis, retinal neovascularization secondary to diabetic retinopathy and venous occlusion and choroidal neovascularization from agerelated macular degeneration (AMD), pathologic myopia, angioid streaks, and neovascular glaucoma. 11 captured owing to errors in coding or cases not reported underestimating its incidence, but it also has the benefit of detailed chart patient review to confirm endophthalmitis’ cases instead of relying on billing codes alone. Second, the retrospective nature of this study made it impossible for us to control for confounding factors. However, this last should not be a significant limitation since endophthalmitis cannot be foreseen by patients or physicians and we believe selection bias with respect to antibiotic prophylaxis use is improbable to occur. Despite these limitations, this study has several strengths. First, we included a large number of IVI performed in a single center over a fairly short period. Second, as this involved a single institution, no difference in the standardized preparation, institution or even physician injection protocol interfered with differences in endophthalmitis rates. Third, the management of endophthalmitis after IVI was homogeneous especially in terms of antibiotic IVI, systemic antibiotic regimen and PPV. Centro Hospitalar de São João performs IVI in an operating room environment and the use of a sterile drape, face mask, surgical hat and sterile gloves is universal. Therefore, extrapolation can be made to other centers and countries with similar conditions but extrapolation for countries using different techniques requires careful consideration. In conclusion, our retrospective study of over 33515 IVI found a low rate of endophthalmitis comparable to prior studies without differences between patients that received and didn’t receive prophylaxis. These results lend support to the safety of stopping topical antibiotic prophylaxis for this common ophthalmic procedure. REFERENCES 1. Campbell RJ, Bronskill SE, Bell CM, Paterson JM, Whitehead M, Gill SS. Rapid expansion of intravitreal drug injection procedures, 2000 to 2008: A population-based analysis. Arch Ophthalmol. 2010. doi:10.1001/archophthalmol.2010.19 2. Keenan TDL, Wotton CJ, Goldacre MJ. Trends over time and geographical variation in rates of intravitreal injections in England. Br J Ophthalmol. 2012. doi:10.1136/bjophthalmol-2011-300338 3. Williams GA. Review of ophthalmology: IVT injections: health policy implications. http://www.reviewofophthalmology.com/content/ d/retinal_insider/c/48732. Published 12 2016. 4. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T. Ranibizumab versus Verteporfin Photodynamic Therapy for Neovascular Age-Related Macular Degeneration: Two-Year Results of the ANCHOR Study. Ophthalmology. 2006. doi:10.1016/j.ophtha.2008.10.018 5. 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Demographics, Management and Bacteriology of Presumed Endophthalmitis Cases (n=13) after Intravitreal Injections (IVI), in Centro Hospitalar Universitário de São João. All (n=13) Topical Antibiotic Prophylaxis p Yes (n=5) No (n=8) Demography Sex (F/M) 10/3 4/1 6/2 1.0 Age* (y) 71 (28-94) 61 (28-85) 78 (61-94) 0.092 Systemic Diseases Diabetes 6 (46.15) 2 (40) 4 (50) 1.0 Hypertension 9 (69.23) 2 (40) 7 (87.5) 0.217 Dyslipidemia 4 (30.77) 0 4 (50) 0.105 Cardiac 4 (30.77) 2 (40) 2 (25) 1.0 Renal 3 (23.08) 2 (40) 1 (12.5) 0.510 Thyroid 3 (23.08) 2 (40) 1 (12.5) 0.510 Ocular Antecedents Iridocyclitis 1 (7.69) 1 (20) 0 0.385 PHACO 9 (69.23) 4 (80) 5 (62.5) 1.0 Indications NAMD 4 (30.77) 0 4 (50) 0.171 DME 3 (23.08) 1 (20) 2 (25) 0.943 Macular edema after RVO 1 (7.69) 1 (20) 0 0.622 Myopic neovascularization 1 (7.69) 1 (20) 0 0.622 Multifocal choroiditis 1 (7.69) 1 (20) 0 0.622 Unknown macular edema 2 (15.38) 1 (20) 1 (12.5) 0.833 Macular edema post-VPP for subluxated LIO 1 (7.69) 0 1 (12.5) 0.724 Agents Ranibizumab 0 0 0 ND Bevacizumab 7 (53.85) 3 (60) 4 (50) ND Aflibercept 3 (23.08) 1 (20) 2 (25) ND Triamcinolone acetonide 2 (15.38) 1 (20) 1 (12.5) ND Dexamethasone implant 1 (7.69) 0 1 (12.5) ND Fluocinolone acetonide implant 0 0 0 ND Number of IVI before endophthalmitis 9 (1-38) 4 (3-25) 11 (1-38) 0.724 Initial Presentation Right/ Left eye affected 9/4 3/2 6/2 1.0 Days to presentation 7 (2-24) 4 (2-16) 16.5 (2-24) 0.171 Vision loss 12 (92.31) 5 (100) 7 (87.5) ND Pain 4 (30.77) 3 (60) 1 (12.5) ND Redness 6 (46.15) 3 (60) 3 (37.5) ND Tyndall 12 (92.31) 4 (80) 8 (100) 0.385 Hypopyon 6 (46.15) 2 (40) 4 (50) 1.0 Corneal Oedema 4 (30.77) 1 (20) 3 (37.5) 1.0 Ocular fundus not visible 10 (76.92) 3 (60) 7 (87.5) 1.0 IOP (mmHg) 12.0 (7.0-50.0) 15.0 (10.0-50.0) 12.0 (7.0-17.0) 0.432 Management Intravitreal antibioticsa 13 (100) 5 (100) 8 (100) ND Intravenous antibioticsb 13 (100) 5 (100) 8 (100) ND PPV 11 (84.6) 5 (100) 6 (75) 0.487 Bacteriology Vitreous and Aqueous Samples 12 (92.31) 5 (100) 7 (87.5) 1.0 Bacterial identification (culture positive) 2 (16.67) 2 (40) 0 0.268 Coagulase-negative Staphylococci 2 (16.67) 2 (40) 0 ND Streptococcus mitis 1 (8.33) 1 (20) 0 ND PHACO= phacoemulsification; NAMD=Neovascular age-related macular degeneration; DME= Diabetic Macular Edema; RVO= Retinal Vein Occlusion; LIO= intraocular lens; IVI= Intravitreal Injections; IOP= Intraocular Pressure; PPV= pars plana vitrectomy Values are displayed as median (range) for continuous variables and number (%) for categorical variables; *mean (range) was considered in this variables. a Vancomycin 1mg and Ceftazidime 2mg. b Vancomycin 1g every 12/12h combined with Ceftazidime 2g every 12/12h for ten days. Comparisons were made with the Fisher exact test for dichotomous data. An independent sample t test was used for continuous variable following a normal distribution and if non-normal a nonparametric Mann-Whitney test was used; ND= Not Determined; the level of statistical significance was set at P < .05; TABLE 3. Visual Acuity (VA) Values and Analysis of Presumed Endophthalmitis Cases (n=13) after Intravitreal Injections, in Centro Hospitalar Universitário de São João. Visual Acuity (logMAR) Previous VA VA at presentation Final VA All (n=13) 0.70 (0.0-2.0) 3.0 (1.0-3.0)a 1.3 (0.0-3.0) Topical Antibiotic Prophylaxis Yes (n=5) 0.40 (0.0-2.0) 3.0 (1.0-3.0) 1.3 (0.0-3.0) No (n=8) 0.90 (0.3-2.0) 3.0 (2.0-3.0)b 1.3 (0.4-2.0) p 0.171 0.548 1.0 LogMAR = logarithm of the minimal angle of resolution; VA = Visual Acuity Values are displayed as median (range) for continuous variables and number (%) for categorical variables; a Limited to n=10 (2 cases of light perception and 1 case without information were excluded) b Limited to n=5 (2 cases of light perception and 1 case without information were excluded) Comparisons were made with the nonparametric Mann-Whitney test, used for continuous variables; the level of statistical significance was set at P < .05. ANEXOS AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 1 OPHTHALMOLOGY RETINA AUTHOR INFORMATION PACK TABLE OF CONTENTS . 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Downloadable Forms Contributorship Form ICMJE Conflict of Interest/Financial Disclosure AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 4 Other Consort Agreement for a Randomized Controlled Trial Cover Art Copyright Assignment Pictures & Perspectives Copyright Submission declaration and verification Submission of an article implies that the work described has not been published previously (except in the form of an abstract, a published lecture or academic thesis, see 'Multiple, redundant or concurrent publication' for more information), that it is not under consideration for publication elsewhere, that its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and that, if accepted, it will not be published elsewhere in the same form, in English or in any other language, including electronically without the written consent of the copyrightholder. 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To learn more about these agreements please visit https://www.elsevier.com/fundingbodies After acceptance, open access papers will be published under a noncommercial license. For authors requiring a commercial CC BY license, you can apply after your manuscript is accepted for publication. Open Access This journal offers authors a choice in publishing their research: AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 5 Open access • Articles are freely available to both subscribers and the wider public with permitted reuse • An open access publication fee is payable by authors or on their behalf (e.g., by their research funder or institution) Subscription • Articles are made available to subscribers as well as developing countries and patient groups through our universal access programs (https://www.elsevier.com/access). Regardless of how you choose to publish your article, the journal will apply the same peer-review criteria and acceptance standards. For open access articles, permitted third party (re)use is defined by the following Creative Commons user licenses: Creative Commons Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) This license allows others to distribute and copy the article for non-commercial purposes or include in a collective work (such as an anthology) as long as authors are properly credited and the article is not altered or modified. Use of inclusive language Inclusive language acknowledges diversity, conveys respect to all people, is sensitive to differences, and promotes equal opportunities. Articles should make no assumptions about the beliefs or commitments of any reader, should contain nothing which might imply that one individual is superior to another on the grounds of race, sex, culture or any other characteristic, and should use inclusive language throughout. Authors should ensure that writing is free from bias, for instance by using 'he or she', 'his/her' instead of 'he' or 'his', and by making use of job titles that are free of stereotyping (e.g. 'chairperson' instead of 'chairman' and 'flight attendant' instead of 'stewardess'). Elsevier supports responsible sharing Find out how you can share your research published in Elsevier journals. The gold open access publication fee for this journal is USD 3300, excluding taxes. Learn more about Elsevier's pricing policy: https://www.elsevier.com/openaccesspricing. Green open access Authors can share their research in a variety of different ways and Elsevier has a number of green open access options available. We recommend authors see our open access page for further information. Authors can also self-archive their manuscripts immediately and enable public access from their institution's repository after an embargo period. This is the version that has been accepted for publication and which typically includes author-incorporated changes suggested during submission, peer review and in editor-author communications. Embargo period: For subscription articles, an appropriate amount of time is needed for journals to deliver value to subscribing customers before an article becomes freely available to the public. This is the embargo period and it begins from the date the article is formally published online in its final and fully citable form. Find out more. This journal has an embargo period of 12 months. PREPARATION Abbreviations/Acronyms and Use of the Active Voice Please refer to the AMA Manual of Style for a listing of acceptable abbreviations and acronyms. On the title page, please define any abbreviations and acronyms that are used in the manuscript. If the manuscript is accepted, this list will be included on the last page of the article in the footnotes as a convenience for readers. Please be sure all abbreviations/acronyms are spelled out at first use in the abstract and again at first use in the text. An abbreviation/acronym should appear first in parentheses immediately after the term or phrase to which it refers. Every abbreviation used in any table or figure should be defined in each corresponding legend. When writing the manuscript, use the active voice whenever possible. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 6 Abstract Abstract A structured abstract is required for Manuscripts, AAO Meeting Papers, and Systematic Reviews or Meta-Analyses. For Reports only: A 35-word unstructured abstract is required for editors'/ reviewers' view only and will not publish with the report. Abstracts for Manuscripts should not exceed 350 words and should be submitted on a separate page in the text. Deletion of any required section of the abstract must be justified in the author cover letter. The following 7 sections must appear in the abstract; please select the most appropriate heading for each section (for example, chose either “Objective” or “Purpose” for the first section): Objective or Purpose: Concisely state the study goal. Design: Identify the study design using a phrase such as cross-sectional study, clinical trial, cohort study, etc. Study design types are summarized in the Study Design section of this guide. The CONSORT Worksheet is required for randomized controlled trials. Subjects, Participants, and/or Controls: Describe the persons or eyes studied and the controls if a separate control group is included. Methods, Intervention, or Testing: Describe the principal treatment(s), procedure(s), test(s), or observation(s) performed. Main Outcome Measures: Define the main parameter(s) being measured (e.g., intraocular pressure, visual acuity, degree of inflammation, etc.) Results: Summarize the principal measurements (data) obtained. Conclusions: State the conclusion(s) derived from the data analysis. Abstracts for Systematic Reviews or Meta-Analyses should not exceed 350 words and must include 5 sections following the PRISMA guidelines: Topic: Provide an explicit statement of the specific clinical question being addressed with reference to a brief description of the participants, interventions (or exposures), comparators, and outcomes examined. Clinical relevance: Characterize the magnitude and importance of the condition; when relevant, define the current standard of care. Methods: Describe the key eligibility criteria for including studies in the systematic review, key databases searched and search dates, and methods of assessing the risk of bias in the individual included studies. Results: Summarize the number and type of included studies and participants, and relevant characteristics of studies; describe the results of main outcomes (benefits and harms), preferably indicating the number of studies and participants for each. If a meta-analysis was done, include summary measures and confidence intervals; report the direction of the effect or association (i.e., which group is favored) and size of the effect using language meaningful to clinicians and patients. Conclusion: Summarize the strengths and limitations of the evidence, your general interpretation of the results, and important implications. Abstracts for Translational Science Reviews are unstructured and should not exceed 350 words. AAO Meeting Papers and Posters AAO Meeting Papers and Posters Ophthalmology Retina has the right of first refusal to any manuscript derived from a presentation at the American Academy of Ophthalmology Annual Meeting. Presentations at the Academy's subspecialty day programs are exempt from this requirement (although submissions from such presentations are welcome). Authors seeking publication may submit their manuscript to the journal before, during, or after the Annual Meeting presentation. Please note on the cover page of the manuscript that it is derived from an Annual Meeting paper or poster. Please be sure to select "AAO Meeting Paper" for the "Manuscript Category"; please do not use "Manuscript" in these instances. A manuscript based on presentation at the AAO Annual Meeting can be submitted to other journals if Ophthalmology Retina declines to accept it after review (as documented by a rejection letter from the journal office) or if a waiver is granted in writing by the Editor-in-Chief. General inquiries about AAO annual meeting abstract submission may be sent to [email protected]. Acknowledgments The journal requires acknowledgment of anyone who makes substantial contributions to a manuscript but does not qualify as an author. Please refer to the Authorship section of this guide, specifically regarding Ghost/Guest Authors. The journal does not allow ghost authors. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 7 The journal will also acknowledge those who reviewed, discussed, edited scientific content, referred patients, translated references, provided extensive statistical assistance, or provided essential tissue, equipment, or other materials without which the study could not have been completed. (See: Lichter PR. The author wishes to thank. Ophthalmology 1988;95:293-4). In such cases, written permission from the person being acknowledged is required. The journal does not print acknowledgments for those who participated in studies (e.g., patients), those who edited for grammar or formatting, or those who provided “helpful” or “moral” support or similar collegial aid to the authors. The journal does not publish acknowledgments of individuals whose service as employees contributed to a study, e.g., secretaries, clinic coordinators, technicians, ophthalmic photographers, or technologists. Astigmatism Reporting Astigmatism For clarity and uniformity, manuscripts about astigmatism should adhere to terminology and graphical representations originally described by Alpins.1-3 An editorial by Reinstein et al outlines the argument for standardization.4 For details of the Alpins methodology and graphical reporting, please consult the following resources: Alpins N. Astigmatism analysis by the Alpins method. J Cataract Refract Surg 2001;27:31-49. Alpins NA. Vector analysis of astigmatism changes by flattening, steepening, and torque. J Cataract Refract Surg 1997;23:1503-14. Alpins NA. A new method of analyzing vectors for changes in astigmatism. J Cataract Refract Surg 1993;19:524-33. Reinstein DZ, Archer TJ, Randleman JB. JRS standard for reporting astigmatism outcomes of refractive surgery. J Refract Surg 2014;30:654-9. Authorship AuthorshipAuthorship Authorship Criteria The journal adheres to the Uniform Requirements set by the International Committee of Medical Journal Editors (http://www.icmje.org/) for authorship. Each author must meet criteria for Authorship. The ICMJE recommends that authorship be based on the following 4 criteria: Substantial contributions to conception and design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published; AND Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. It is the responsibility of the corresponding author to confirm that each coauthor meets the requirements for authorship. These ICMJE forms should be uploaded during the revision stage. Please note that the list of contributions will publish with the manuscript should it be accepted. Ghost/Guest Authors Please note that the journal does not allow ghost authorship, based on the definition of ghost authorship as the failure to designate an individual who has made a substantial contribution to the research or writing of a manuscript (JAMA 2008;299(15):1800-12). If it comes to light that a substantial contribution has not been disclosed, the journal shall advise the corresponding author and withdraw the submission. Based on the definition of guest authorship as the designation and acknowledgment of an individual who has contributed significantly but does not meet authorship criteria, any guest authors must (a) provide written permission to the corresponding author which is to be uploaded with the submission and (b) be listed by the corresponding author in the acknowledgments section (after text and before references in manuscript file) for their contribution (e.g., James Smith for statistical analysis). If the guest author is being acknowledged for writing assistance, it should specifically address if the guest author prepared a manuscript draft for the named authors to edit or if the named authors prepared the manuscript and received writing and formatting assistance from the guest author. If not selfemployed, the guest author should disclose the name of his/her employer and any funding sources. Corresponding Author The corresponding author is the person responsible for a submission and all communication with the journal regarding a submission. The corresponding author must notify the editors and editorial office, via the submission form, of the following: Acknowledgment of any guest author, defined as AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 8 an individual who does not meet authorship criteria but has made a substantial contribution to the research or writing of a manuscript. Confirmation that there are no “ghost authors,” defined as an individual who has made a substantial contribution but does not qualify as an author and has not been disclosed to the editor. Submission of ICMJE conflict of interest and copyright forms from all authors; conflict of interest forms are required and requisite disclosures should be reported on the manuscript’s cover page.Submission of the Contributorship Form (see downloadable forms). Acknowledgment of funding by the US National Institutes of Health (NIH). Articles accepted for publication in Ophthalmology Retina from authors who have indicated that the underlying research reported in their articles was supported by an NIH grant will be sent by Elsevier to PubMed Central for public access 12 months after publication. The version of the article provided by Elsevier is the final accepted version after peer-review but before copyediting. Confirmation that Institutional Review Board issues have been addressed in the Methods section of the main manuscript. Confirmation that the authors are aware the journal occasionally, only after acceptance of a submission and on a confidential basis and with no rights prior to embargo date, shares some information with the American Academy of Ophthalmology public relations staff and/or EyeNet staff. After acceptance for publication, authors may designate more than one person to be contacted by readers. Study Group/Writing Committee Authorship If study group/writing committee authorship is used and the corresponding author is the study chair, please state this on the cover page. However, if he/she is not the study chair, please enclose with the submission a statement from the study chair that the group authorship as stated on the cover page and/or members of the responsible writing committee are both correct. The journal promotes transparency of authorship to editors, reviewers, and readers. Members of the group can be listed in initial group papers in print and in subsequent papers, either by reference to an earlier manuscript, or at times for length and format reasons, in online supplemental material. Members are appropriately acknowledged by the byline “…for the XYZ Study Group” or “… on behalf of the XYZ Group.” If you believe group members are more appropriately acknowledged by including them as authors, each must meet authorship criteria and complete the required ICMJE authorship criteria, copyright assignment, and conflict of interest forms. With transparency and space limitations in mind, the following are the journal’s policies regarding study group/writing committee authorship: If an individual is authoring for a group (e.g., a Study Chair) it should be listed as Henry A. Fiddle, MD for the Laser ROP Study Group Small study groups (≤ 10 members) can author as the group or they can list writing committee members names “and the XYZ Study Group” as long as all the members qualify as authors. Otherwise, only those who qualify should be listed and the remainder can be acknowledged. Debra L Hanson, MS; Susan Y. Chu, PhD; Karen M. Farizo, MD; John W. Ward, MD; and the Adult and Adolescent Spectrum of HIV Disease Project Group Large study groups (>10 members) should not author a paper as an entity. In large groups it is not likely that every single member of the group or network contributed as required by the authorship criteria mentioned above. Large study groups should either list the writing committee members as authors and then “for the XYZ Study Group” or list “Writing committee for the XYZ Study Group*” as the author and the names of the writing committee members will be listed at the end of the article with the asterisk. Regardless, members of the writing committee must qualify as authors and complete the appropriate ICMJE authorship forms. Debra L Hanson, MS; Susan Y. Chu, PhD; Karen M. Farizo, MD; John W. Ward, MD for the Adult and Adolescent Spectrum of HIV Disease Project Group OR The Writing Group for the DISC Collaborative Research Group* OR The DISC Collaborative Research Group Writing Committee* Any digression from these authorship guidelines must be addressed, prior to submission, via email to [email protected]. The Editorial Director and/or Editor-in-Chief will discuss with the corresponding author on a case-by-case basis. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 9 Entering Authors into the Submission System Enter the title, first and last name, email address, and country for all authors. The number of authors on the submission form must match the list on the title page. Be sure to indicate which author is the corresponding author by checking the appropriate box. All correspondence regarding a submission must come from and will be sent to the corresponding author only. Author order can be changed by changing number order next to the author's name, then clicking "Save" to update the order. Please do not have staff members list themselves as authors for the purpose of uploading files. NOTE: Once a manuscript has been submitted, the order of authorship (including adding or removing authors) cannot be changed without a written request to the Editorial Office from the corresponding author. The request must include a statement that all authors are in agreement with the change and signed by all authors. Specifically, if an author is removed, a letter from that author agreeing to his/her removal is required. If the authors are not able to agree among themselves on authorship changes, please withdraw the paper. The editors and Editorial Office do not arbitrate such debates. Authorship changes cannot be submitted with proof changes. The publisher is not authorized to make such changes. Cancer Classifications We encourage authors to use the American Joint Commission on Cancer TNM Classification scheme when describing patients with ophthalmic malignancies. AJCC Cancer Staging Manual. (7th ed. New York, NY: Springer; 2009). The classification scheme can also be found at https://cancerstaging.org/references-tools/Pages/What-is-Cancer-Staging.aspx. Clinical Trials and Clinical Trial Registration A clinical trial is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. With regards to the reporting of clinical trials, Ophthalmology's policies are similar to the policies of The New England Journal of Medicine (NEJM), and The Journal of the American Medical Association (JAMA) which can be viewed at http://jama.ama-assn.org/misc/authors.dtl. Consistent with these policies, prospective clinical trial registration is required. Please state in the Methods section where the clinical trial registration information is publicly available. Satisfactory public databases include the NIH's http://www.clinicaltrials.gov and the site from the International Standard Randomized Controlled Trials at http://www.controlled-trials.com. For all manuscripts that report clinical trials, CONSORT guidelines must be followed, including submission of a CONSORT flow diagram and checklist. Ophthalmology Retina supports the National Institutes of Health Principles and Guidelines for Reporting Preclinical Research. Please refer to the following site for additional information: http://www.nih.gov/about/reporting-preclinical-research.htm Conflict of Interest (financial disclosure) Each co-author must complete an ICMJE Conflict of Interest Form and submit it to the corresponding author. Although the ICMJE form requires “potential” and “relevant” conflicts, to promote transparency we request authors to report all financial relationships. Mutual funds need not be listed. Such disclosure will not affect the review of the manuscript. For further information, please refer to: Liesegang TJ, Schachat AP. Enhanced reporting of potential conflicts of interest: rationale and new form. Am J Ophthalmol 2011:151:391-3. Liesegang TJ, Bartley GB. Toward transparency of financial disclosure. Ophthalmology 2014;121:2077-9. Liesegang TJ, Bartley GB. Footnotes, acknowledgments, and authorship: toward greater responsibility, accountability, and transparency. Ophthalmology 2014;121:2297-8. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 16 Reporting Refractive Surgery Outcomes and Astigmatism Astigmatism_Reporting_links_to_Reporting_Refractive_Surgery_Outcomes_and_AstigmatismWhen reporting refractive surgery outcomes, please include 6 graphs to illustrate the following (references 1-3): Uncorrected distance visual acuity Change in corrected distance visual acuity Spherical equivalent (attempted versus achieved) Spherical equivalent refractive accuracy Spherical equivalent refraction stability Refractive astigmatism Descriptions of astigmatism should adhere to terminology and graphical representations originally described by Alpins (references 4-6). An editorial by Reinstein et al (reference 7) presents the argument for standardization. Waring GO III, Reinstein DZ, Dupps WJ, Kohnen T, Mamalis N, Rosen ES, Koch DD, Obstbaum SA, Stulting RD. Standardized graphs and terms for refractive surgery results. J Refract Surg 2011;27:7Erratum in J Refract Surg 2011;27:88. Reinstein DZ, Waring GO III. Graphic reporting of outcomes of refractive surgery. J Refract Surg 2009;5:975-8. Waring GO III. Standard graphs for reporting refractive surgery. J Refract Surg 2000;16:459-66. Erratum in J Refract Surg 2001;17:following table of contents. Alpins N. Astigmatism analysis by the Alpins method. J Cataract Refract Surg 2001;27:31-49. Alpins NA. Vector analysis of astigmatism changes by flattening, steepening, and torque. J Cataract Refract Surg 1997;23:1503-14. Alpins NA. A new method of analyzing vectors for changes in astigmatism. J Cataract Refract Surg 1993;19:524-33. Reinstein DZ, Archer TJ, Randleman JB. JRS standard for reporting astigmatism outcomes of refractive surgery. J Refract Surg 2014;30:654-9. Erratum in: J Refract Surg 2015;3:129. Reports Reports are typically submitted after invitation from the Editorial Board. Specifically, some full-length manuscripts contain noteworthy information that can be presented in a more concise communique. The Editorial Board may invite the authors to abridge their work, taking into consideration suggestions for revision in the initial reviews, and resubmit the paper as a Report. Reports do not exceed 1000 words or include more than 5 references, and may feature one figure, graph, chart, or concise table on the print version. Two additional items can be included as online supplemental material. Please insert “(available at https://www.ophthalmologyretina.org/)” at relevant point(s) in your manuscript. Please note that online supplemental material must conform to the same requirements regarding legends, abbreviations, etc. as for the print publication. A 35-word unstructured abstract is required for editors'/reviewers' view only and will not publish with the report. The text should be in narrative rather than a structured format. When uploading Reports, please select the “Case Report” submission type, select "Manuscript to Report (Invited)" as the Manuscript Category, and include the manuscript number of the original submission on the cover letter. Please include a point-by-point response to the original reviewer(s)’ questions and suggestions. Please note that an acknowledgment section is reserved for grants and funding only. Review Articles Systematic Reviews and Meta-analysis Systematic reviews seek to collect and critically assess all evidence that fits pre-specified criteria to answer a clinical question pertaining to the cause, diagnosis, prognosis, prevention, or therapy for a condition. A systematic review may contain a meta-analysis, which uses statistical methods to combine results from similar but independent studies. Features of a systematic review include “a clearly stated set of objectives with pre-defined eligibility criteria for studies; an explicit, reproducible methodology; a systematic search that attempts to identify all studies that would meet the eligibility criteria; an assessment of the validity of the findings of the included studies, for example through the assessment of risk of bias; and a systematic presentation, and synthesis of the characteristics and findings of the included studies (Higgins JPT, Green S (editors). Chapter 1. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011). It is possible to conduct a systematic review and meta-analysis of the evidence supporting any type of research question, whether the question is about intervention effectiveness or harm, etiology, prognosis, diagnostic accuracy, toxicity, incidence, or prevalence. Where intervention effectiveness questions are typically addressed by randomized controlled trials, most other questions are addressed using observational studies. Systematic reviews may be conducted for human or animal studies, in vivo or in vitro. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 17 For standards and classic references in conducting systematic reviews and meta-analyses, please refer to: Institute of Medicine. Finding what works in health care: standards for systematic reviews. 2011.Chandler J, Churchill R, Higgins J, Tovey D. Methodological standards for the conduct of new Cochrane Intervention Reviews. Version 2.2. 17 December 2012.Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Handbook for Diagnostic Accuracy Reviews [Draft]Little J, Higgins JPT (editors). The HuGENE™ HuGE Review Handbook, version 1.0. Guidelines for systematic review and meta-analysis of gene disease association studies (see also Systematic Reviews of Genetic Association Studies, PLoS Medicine 2009;6(3):e1000028)Systematic Reviews. CRD's guidance for undertaking reviews in health care. Centre for Reviews and Dissemination, University of York, 2009 For reporting systematic reviews and meta-analyses, if you are submitting a report ofA systematic review and/or meta-analysis of randomized controlled trials, please follow the PRISMA guidelines for reporting; A systematic review and/or meta-analysis of observational studies, please follow the MOOSE guidelines for reporting. A complete list of guidelines for reporting systematic reviews and meta-analyses can be found at the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network’s website. We strongly recommend you visit the EQUATOR’s website for reporting guidelines for systematic reviews and meta-analyses of other study designs (e.g., individual participant data, health equity, genetic association studies). The Cochrane Collaboration also has developed Standards for the Reporting of Cochrane Intervention Reviews. Title Page: The title should clearly describe the research question and identify the report as a systematic review, meta-analysis, or both in the subtitle. (Example: Anti-vascular endothelial growth factor for neovascular age-related macular degeneration - A systematic review and meta-analysis.) Prcis: The prcis should indicate a new insight the article offers or a principal controversy that is addressed. Structured Abstracts: Abstracts for systematic reviews and meta-analysis must be limited to 350 words and include five sections following the PRISMA guidelines: Topic: provide an explicit statement of the specific clinical question being addressed with reference to a brief description of the participants, interventions (or exposures), comparators, and outcomes examined. Clinical relevance: characterize the magnitude and importance of the condition; when relevant, define the current standard of care. Methods: describe the key eligibility criteria for including studies in the systematic review, key databases searched and search dates, methods of assessing the risk of bias in the individual studies. Results: summarize the number and type of included studies and participants, and relevant characteristics of studies; describe the results of main outcomes (benefits and harms), preferably indicating the number of studies and participants for each. If a meta-analysis was done, include summary measures and confidence intervals; report the direction of the effect or association (i.e., which group is favored) and size of the effect using language meaningful to clinicians and patients. Conclusion: summarize the strengths and limitations of the evidence, your general interpretation of the results, and important implications. Note that the abstract content and conclusions should agree with what is in the manuscript text. Manuscript text The text should use standard journal formatting and be divided into four distinct sections. The brief descriptions below are gathered from the PRISMA, the MOOSE guidelines, and the Standards for the Reporting of Cochrane Intervention Reviews. The text should report institutional review board approval or exemption, financial disclosures and potential conflicts of interest of the authors, and funding sources of the review. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 18 1. Introduction (unlabeled) should provide a concise description of the condition or clinical problem addressed by the review question, provide perspectives on the importance of its management to patient well-being and quality of life, and why it is important to do the review. Always end the introduction with a clear and concise statement of the study's main objectives or hypotheses. 2. Methods: The methods section should include the following subheadings: Eligibility criteria for considering studies for this review: state eligibility criteria for participants, interventions (or exposures) and comparators, and eligible study design(s) if applicable. Define primary and secondary outcomes of the review and state whether an article had to report measurement of at least one of the outcomes to be eligible. If so, provide rationale. Search methods for identifying studies: list all information sources searched, including databases, trial registries, websites, difficult-to-access literature (e.g., grey literature, conference proceedings), reference lists of included studies, and whether individuals or organizations were contacted. For all searches, provide the date of the last search and whether there was any time period or language restriction. Present the exact full search strategy (or strategies) used for at least one database in an Appendix with sufficient detail to permit replication. Report which software was used to manage the records identified and eligibility status. Study selection: describe the process for selecting studies, how many people were involved at each step of the review, whether any steps were done by more than one person, and if so whether they worked independently and how different opinions were resolved. Data collection and risk of bias assessment: List and define data items extracted from the reports of included studies. Describe methods used for assessing risk of bias of included studies (risk of bias is a formal assessment of what is often considered study "quality"), and how this information was used in any data synthesis. Describe the process for data extraction and risk of bias assessment, how many people were involved at each step, whether any steps were done by more than one person, and if so whether they worked independently and how different opinions were resolved. Report the software used for data collection and management. Data synthesis and analysis: state the methods for combining results across studies, which include qualitative synthesis (see Chapter 4, section on "Qualitative Synthesis of the Body of Evidence; Finding what works in health care: standards for systematic reviews) and quantitative synthesis (i.e., meta-analysis). State the summary measures used to quantify the treatment effect or association such as risk ratio, odds ratio, and difference in means. Describe methods for assessing clinical, methodological, and statistical heterogeneity (e.g., I2 statistic, tausquared, statistical test). Describe methods for additional analyses such as meta-regression, subgroup analysis, and sensitivity analysis, if done, indicate which were pre-specified. State the statistical software used for analysis. Indicate whether a systematic review protocol exists, if so, where and how it can be accessed; and if available, provide systematic review registration information including registration number. 3. Results: Provide numbers of studies retrieved, screened, assessed in full for eligibility, included in the review, and included in the meta-analysis, with reasons for exclusion at each stage, ideally with a flow diagram. Present characteristics of included studies including information on the study design, participants, interventions (or exposures) and comparators, outcomes, and source of funding, ideally in a table. Present domain-based risk of bias assessment of each study, ideally in a table or a figure. Composite quality scores and scales are discouraged. For all outcomes considered, irrespective of the direction or strength of the results, present, (1) simple summary data for each group, and (2) estimates of treatment effect (or association) between groups with a measure of statistical uncertainty (e.g., confidence intervals). If meta-analysis was done, report meta-analytical results ideally with a forest plot, number of studies and participants for each meta-analysis, as well as measures of statistical heterogeneity. Present results of any additional analyses (such as meta-regression, subgroup analysis, and sensitivity analysis) if done. Provide a thoughtful qualitative synthesis by analyzing the nature, strengths, and weaknesses of the evidence, and developing a deeper understanding of how an intervention might work (or not), or whether a true association exists, for whom and under what circumstances. 4.Discussion: Summarizes the main findings including the strength of evidence for each main outcome. Provide a general interpretation of the evidence considering their relevance to key stakeholders, including patients, healthcare providers, researchers, payers, and policy makers. A Summary of Findings or GRADE table is optional. Discuss limitations at study and outcome level AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 19 (such as risk of bias), and at review level (such as incomplete retrieval of identified studies, reporting biases). Provide a general interpretation of the results in the context of other evidence, and implications for practice and future research. In the cover letter to the Editor, please state explicitly (1) whether reporting guidelines have been followed, if so, which reporting guidelines; (2) whether the exact full search strategy (or strategies) used for at least one database was presented in an Appendix with sufficient detail to permit replication. Failure to follow the reporting guidelines or upload the search strategy may result in delay in review or rejection of the manuscript. Please submit a PRISMA worksheet and diagram as separate files. Checklist: prisma-statement.org/documents/PRISMA%202009%20checklist.doc Diagram: prisma-statement.org/documents/PRISMA%202009%20flow%20diagram.doc Translational Science Reviews Translational Science Reviews aim to provide authoritative summaries of state-of-the-art research that bridges the gap between basic and clinical science and which may have broad clinical impact within a few years. For example, in the years prior to the FDA approval of anti-VEGF drugs to treat neovascular age related macular degeneration, an article in this section might have summarized the relevant basic research that supported Phase 1 human studies for anti-VEGF drugs that are now widely used. Manuscripts should be broadly accessible as the intended audience includes ophthalmologists whose primary focus is usually clinical practice. Please avoid jargon and do not assume that laboratory techniques will be understood by all readers. Translational Science Reviews are usually solicited by the editor for this section, Marco Zarbin, M.D., Ph.D. Suggestions for topics are welcome, however, and can be directed to Dr. Zarbin (send suggestions to [email protected] and add "TSR" in the subject line). Statistics Statistical methods must be identified in table footnotes, illustration legends, or text explanations. Software programs used for complex statistical analyses must be identified to enable reviewers to verify calculations. For manuscripts in which the study conclusions infer equivalency in treatment effect, a sample size calculation and power analysis should be included. Levels for alpha and beta errors should be clearly stated in the Methods section of the Abstract and text. Authors should state the clinically significant difference that was used to determine the power calculation. The journal strongly advises statistical consultation about data collection and analysis. We follow The New England Journal Medicine’s guidelines for reporting P values: Except when onesided tests are required by study design, such as in non-inferiority trials, all reported P values should be two-sided (except when one-sided tests are required by study design). In general, P values larger than 0.01 should be reported to 2 decimal places, those between 0.01 and 0.001 to 3 decimal places; P values smaller than 0.001 should be reported as P < 0.001. Notable exceptions to this policy include P values arising in the application of stopping rules to the analysis of clinical trials and genetic-screening studies. For tables comparing treatment or exposure groups in a randomized trial (usually the first table in the trial report), significant differences between or among groups should be indicated by * for P < 0.05, ** for P < 0.01, and *** for P < 0.001 with an explanation in the footnote if required. The body of the table should not include a column of P values. Study Design Authors are asked to describe the design of their study as part of the structured abstract. Doing so serves several purposes. It encourages authors to give careful thought to what they have actually done, it provides a useful shortcut for editors and reviewers to categorize the submission, and it gives the reader a useful descriptor of the type of study that was performed. The CONSORT Worksheet http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Checklist.doc for randomized controlled trials has been required since 1996 and is available online. The following chart (https://www.elsevier.com/__data/promis_misc/OPHTHA_STUDY_DESIGN.docx) provides basic information regarding study designs. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 20 Tables Tables require substantial space; please give careful consideration to the number of tables submitted and design tables to fit on one formatted page. The information should not be extensively iterated in the text. Place the information in the text or in a table but not both. Each table must be titled and numbered consecutively as mentioned in the text. Each column must have a heading. Terminology used within tables should be able to stand independently, without the requirement of explanation from the text. Use abbreviations and acronyms only if imperative for reasonable table formatting. All abbreviations and acronyms must be explained in the table legend. References for tables should be included in the main reference list. If unpublished data or abstract need to be referenced in a table, please place it as a footnote. Tables for print publication must be uploaded as individual Word documents, one table per file. If a table is longer than one page in Microsoft Word, it may be too large to print and would work better as an online-only Supplemental Table. Online-only Supplemental Tables must be uploaded as PDF files, one table per PDF file. Supplemental Tables must be uploaded as “e-Component” file types to your submission. Video Clips If submitting video as an online supplement, add a reference to it in parentheses at an appropriate place within the text of the manuscript. Also, add a statement to the title page that should read similar to “This article contains a video as additional online-only material. The following should appear online-only: Clip 1, Clip 2 and Clip 3.” The materials will be archived with the online version on the publisher’s website. We do not have video editing software, but a website with useful tips on reducing file size can be found at http://www.deskshare.com/Resources/articles/dmc_ReduceFileSize.aspx Maximum: 8 minutes total. We recommend several smaller clips that do not exceed 8 minutes. Size: recommended size 10-50 MB, and the maximum size is 100 MB. File extension types: .MPG (MPEG-1 or 2), .AVI, .MOV Upload a still image of each video clip. Audio commentary to describe the video is highly recommended. Please do not use background music. Within the submission, there must be a brief legend describing contents of the video and indicates the viewing order. Video files should be loaded with the submission into the electronic submission system. File names should correspond to video legends. On the title page include “This manuscript contains [insert number of video clips]. Upload with submission using the “multimedia” file type. REVIEW PROCESS Review and Publication Process It is the corresponding author’s responsibility to check periodically the status of his/her manuscript. An email with a decision will be sent with instructions to the corresponding author to go to the online submission site if a revision is warranted. Each manuscript submission will be acknowledged in the order received in the Editorial Office. The acknowledgment letter will note the number assigned to the manuscript. All subsequent inquiries about the manuscript must indicate the manuscript number. Usually two and sometimes several reviewers and Editorial Board members will participate in the review of a manuscript. The journal does not reveal the identity of its reviewers but does provide pertinent comments to the corresponding author. Re-review may be required after revision if, in the judgment of the Editor-in-Chief, sufficient modification of the manuscript or data justifies another review cycle or if one (or more) of the reviewers requested to see the revision. A point-by-point response is required to the reviewers’ comments. Authors should upload two versions of the revised manuscript – one showing “track changes” to show where revisions have been made and a “clean” copy. Revised manuscripts are due within 60 days. Revision Submission If invited to revise a manuscript, the corresponding author will receive an email that contains the revise decision as well as the reviewers’ and/or editors’ comments. Log on as an author to https://www.evise.com/profile/api/navigate/ORET with your user name and password. The manuscript will be in the author menu under “My submissions that need revision” AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 21 Review the editor/revision comments and, as appropriate, make changes to files based on these comments as well as the editorial office comments. Save two versions of the manuscript file – one showing “track changes” and the other a clean copy with all changes accepted. When all files are revised, go to https://www.evise.com/profile/api/navigate/ORET. Under “My submissions that need revision” select “Agree to Revise” to start the revision submission. Instructions are provided on how to upload revised files and replace old ones in the “Upload Files” section. The following File Types are required to submit a revised article: Manuscript File (the clean revised version) Revised Manuscript File with Track Changes Highlights (Précis) Author Agreement (Contributorship Form) Conflict of Interest (ICMJE form, one per author) Cover Letter Response to Reviewers (Point-by-Point response) A final opportunity is provided to review the completed revised version before clicking the final button “Complete Submission.” Please read and acknowledge the Ethics in Publishing statement before final submission. If you elect to withdraw your paper rather than submit a revision, please log on to the system and select “Decline to Revise.” PLEASE REMEMBER: Point-by-point response: Please include a point-by-point response to each of the comments from the reviewer(s), editor(s), and/or editorial office. One technique that has proved useful both for authors and the Editorial Office is to create a 3-columned table, in a Word file, to summarize your revisions. (See template https://www.elsevier.com/__data/promis_misc/oph-template-form.docx and sample https://www.elsevier.com/__data/promis_misc/oph-sample-form.docx.) In the first column, list the reviewer's suggestion, question, or comment. In the second column, outline your response. If you disagree with the reviewer, please explain your reasoning. In the third column, specify where in the manuscript you have made any changes. Adding line numbers to the manuscript file and referring to specific line numbers will be useful in determining which parts of the manuscript changed. Please ensure that revisions in the text are also changed in any relevant tables or figures. References: At first revision, please review the reference format style guide and ensure that references are in the correct format.To expedite processing of a revised manuscript, please provide a photocopy of the title page (including journal name, volume number, year, page numbers) of any work cited that was published prior to 1970 in the United States. This information can be submitted as “related file.” Figures: Please note any changes to figures in the point-by-point response.If applicable, the revision decision letter will provide instructions on how to prepare figures to meet specific artwork guidelines for the publisher. If you cannot meet these guidelines, contact the editorial office before submitting your revisions.Please insert into the text at first mention of the supplemental figures “(available at www.aaojournal.org)” as well as specify on the cover page which figures are to be online-only supplemental materials. Authors: Please ensure the manuscript title on the cover page matches the title entered into the submission system. Any changes to authors require written explanation, as detailed above under “Authorship.” File submission: Please upload two versions of your revised manuscript -- one showing “track changes” and one that is “clean.” Do not submit more than one version of any other file type unless specifically requested by the editorial office. Each file, revised or not, should be the current version of the submission. If not done with the initial submission, ICMJE conflict of interest forms from all authors and the Contributorship Form must be included at revision. Rejection of Manuscripts By Other Journals Rejection by another journal does not compromise consideration by Ophthalmology Retina. Authors are required to inform the Editor-in-Chief of rejection by another journal on the cover letter and include copies of the previous review commentary and the authors’ responses. Please use the point-by-point response template: https://www.elsevier.com/__data/promis_misc/oph-template-form.docx. Appeals Regarding Manuscripts Rejected by Ophthalmology Retina Ophthalmology Retina is able to accept a relatively small percentage of submissions received. Therefore, many good manuscripts have to be declined, oftentimes despite favorable peer reviews. If your paper is rejected but the reviews are accurate, please do not appeal the decision and request additional reviews. Doing so distracts the journal's editors and reviewers from evaluating submissions AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 22 and editorial staff from processing other manuscripts and is unfair to the authors of those papers. If, however, the reviewer or editor assessments are in reconsidered, the Editor-in-Chief will entertain an appeal and reopen the manuscript's file. Any appeal must be made by the corresponding author to the Editorial Office by email prior to resubmitting the manuscript. Please do not resubmit until your original manuscript is released back to you. By waiting for the manuscript release, it ensures that your paper is processed under the same manuscript number, keeping the manuscript history intact. Occasionally, a manuscript is rejected but the Editorial Board offers the option to resubmit a revised, abridged version as a Report. Please see the Report section for details. Reference management software Most Elsevier journals have their reference template available in many of the most popular reference management software products. These include all products that support Citation Style Language styles, such as Mendeley. Using citation plug-ins from these products, authors only need to select the appropriate journal template when preparing their article, after which citations and bibliographies will be automatically formatted in the journal's style. If no template is yet available for this journal, please follow the format of the sample references and citations as shown in this Guide. If you use reference management software, please ensure that you remove all field codes before submitting the electronic manuscript. More information on how to remove field codes from different reference management software. Users of Mendeley Desktop can easily install the reference style for this journal by clicking the following link: http://open.mendeley.com/use-citation-style/ophthalmology When preparing your manuscript, you will be able to select this style using the Mendeley plug-ins for Microsoft Word or LibreOffice. Data statement To foster transparency, we encourage you to state the availability of your data in your submission. This may be a requirement of your funding body or institution. If your data is unavailable to access or unsuitable to post, you will have the opportunity to indicate why during the submission process, for example by stating that the research data is confidential. The statement will appear with your published article on ScienceDirect. For more information, visit the Data Statement page. AFTER ACCEPTANCE Proofs If the submission is accepted, the corresponding author will receive typeset page proofs online. Each corresponding author is expected to proofread all pages carefully and answer all queries posed by the copy editor. Page proofs should be reviewed by more than one person to enhance accuracy. All page proofs must be returned to the publisher within 72 hours of receipt to avoid delay in publication. The publisher does not send reminders; responding to the publisher with responses to author queries and requested changes is the corresponding author’s responsibility. The journal reserves final editorial approval for style, format, and grammar. Reprints A reprint order form will either be e-mailed or accompany your copyedited manuscript and page proofs. You must return this form to the publisher with your corrected page proofs, whether or not you order reprints. The cost of reprints increases significantly if they are ordered after the initial print run. Reprints, except special orders of 100 or more, are available only for authors. Cover Figures Ophthalmology Retina publishes photographs and images on the cover of the printed journal. The images are selected by the Editorial Board. We will consider submissions for cover figures accompanied by a descriptive caption from professional ophthalmic photographers and clinicians. Cover figures are sometimes generated from figures in articles appearing in a given issue. Images should be visually striking, technically excellent, and of appropriate size for the cover format. AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 23 To submit an image for consideration as a cover, please send the files to the editorial office at [email protected]. Please use the subject header “Cover Image for Ophthalmology Retina” so that the e-mail is appropriately flagged. Send the editorial office a JPG version of the image along with a photograph title, photographer and institutional affiliation, and equipment used to capture the image. If the photograph is appropriate, the editorial office will work with the submitter to generate appropriate file(s) for publication (see technical considerations below). If an image is selected for use as a potential cover image, Ophthalmology Retina will need a completed copyright transfer form (see downloadable forms). Once the form is received, the editorial office will assign the image for a future issue. Please be aware it may be several months before it appears in print. Technical Considerations The four-color printing process used in producing the journal cover requires high resolution files to achieve the best quality. Should an image be chosen for the cover, the file(s) should be available as minimally compressed JPG or ideally uncompressed (e.g., TIF or PSD) high resolution files of at least 8"x8" at 300 dpi. Screen grabs from video (even high definition video) do not upscale adequately for print and can appear blurred; similarly, output from most diagnostic instruments do not upscale well and can look pixelated. Please do not perform any post-processing of the digital image other than light dusting and spot removal. sRGB colorspace is fine; do not convert to CMYK as this will be done by the publisher during pre-press processing. The high resolution files for final publication are usually too big to send by email. A web-based large file transfer service (e.g., http://www.yousendit.com) can be used; please contact the editorial office ([email protected]) if you need assistance with transmitting large files. Copyright Considerations Copyright for image(s) must be transferred to the American Academy of Ophthalmology. The copyright transfer form must be signed by all listed authors. Please note that if the image has already appeared as part of an article in another journal or in a textbook, the author or photographer probably does not have the right to transfer the copyright to the AAO. Similarly, if the image has appeared as part of a photography contest (and especially if it won a prize), the conditions of contest participation should be clarified. The copyright transfer form should be submitted to the editorial office at [email protected]. In Press/Online Release Availability of Accepted Article This journal makes articles available online as soon as possible after acceptance. This concerns the accepted article (both in HTML and PDF format), which has not yet been copyedited, typeset or proofread. A Digital Object Identifier (DOI) is allocated, thereby making it fully citable and searchable by title, author name(s) and the full text. The article's PDF also carries a disclaimer stating that it is an unedited article. Subsequent production stages will simply replace this version. Manuscripts are available online as "in press" articles after completing the publisher’s proofing process. The online release is not a draft version since it is produced after all editorial and author corrections are made; however, there is a disclaimer in case a critical error is found. No routine editing will occur once an article appears online. The "in press" designation is removed as soon as the monthly issue is available online. It is the corresponding author's responsibility that all editing be done at the time the original proofs are received from the publisher and that the publisher is notified immediately if the authors do not wish to have the "in press" article released online. All notifications regarding proof approvals, proof corrections, or requests that an article not be released "in press" prior to publication must come from the corresponding author and sent to Katy Powers ([email protected]). AUTHOR INFORMATION PACK 8 Feb 2019 www.elsevier.com/locate/oret 24 Data Sharing To promote transparency and opportunities for further research, authors of work published in Ophthalmology Retina are encouraged to provide access to relevant datasets in compliance with contemporary reporting standards. Authors may use domain-specific public archives (for example, ClinicalTrials.gov, GenBank, Protein Data Bank), or generic databases (for example, Dataverse, Dryad, Mendeley, or the Open Science Framework, or an institutional repository). For additional information, please consult: Taichman DB, Backus J, Baethge C, et al. Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors. JAMA 2016;315(5):467-468. AUTHOR INQUIRIES If you have questions about the submission process or are unable to access the system, please contact the editorial office by e-mail at [email protected] or by phone at 415-447-0261. Communication about manuscripts occur primarily through email and only with corresponding authors, so it is important for authors to keep their contact information (address, institution, phone numbers, and e-mail address) current. © Copyright 2018 Elsevier | https://www.elsevier.com